Information for Reviewers

Text in black is part of the template used to create this document and is not under review. Please review the blue text; this text represents the changes made to the template that are specific to this QRS instrument.

Title	Columbia-Suicide Severity Rating Scale Baseline (C-SSRS BASELINE)
CDISC Reference	Questionnaire Supplement to the Study Data Tabulation Model Implementation Guide for Human Clinical Trials
QRS Short Name	C-SSRS BASELINE
QRS Permission Status	Approved
Team	CDISC Questionnaires, Ratings, and Scales (QRS) Subteam
Supplement Version	1.3
Status	REVISION DRAFT
Date	2022-08-11
Notes	This supplement is intended to be used with other CDISC user guides for specific therapeutic/disease areas and follows the CDISC Study Data Tabulation Model Implementation Guide for Human Clinical Trials.

Revision History

Date	Version	Summary of Changes
2021-09-22	1.3 Draft	Converted the supplement to the current WIKI QRS supplement template. Annotated CRF updated to the MSG V2.0 annotation guidelines, including following updates: a. Change of QSEVLINT to QSEVINTX for the Evaluation Interval Text of "LIFETIME" b. Added annotations for QSSTRESC/QSSTRESN wherever applicable Added the first assumption to include details on every item of the instrument. The QSEVAL and QSEVALID assumption and variables were removed from this supplement since it is not captured on the CRF and no assumptions are made on the potential values. Added assumptions 4, 5 and 6 for conditional branching. The example was updated to include records for these items. Added QSLOBXFL variable to the example to represent a baseline response for visit 1 Added example to represent skipped visit (visitnum = 2) Added QSDRVFL variable to the example to represent items not done due to conditional branching. Section 4 (SDTM mapping strategy): Added an additional column in the table for "Most Recent Attempt", "Most Lethal Attempt" and "Initial/First Attempt" (QSTESTCD = "CSS0121B", "CSS0122B", and "CSS0123B") to indicate CRF Text over 200 characters Added example for SUPPQS dataset Added section 5 Supplemental Qualifier Name Codes.
2014-09-03	1.2	Columbia-Suicide Severity Rating Scale Baseline (C-SSRS BASELINE) Revised: Updated references to QSCAT and questionnaire name throughout the document. Section 3.1: Assumption # 2 – Evaluation Interval mapped to QSEVINTX (from EVLINTTX). Section 3.2: Updated text above example table. Example table updated to include QSEVINTX in the QS table. Removed the SUPPQS.xpt table. Section 4: (SDTM Mapping Strategy) for QSTESTCD=CSS0111. Old value: Completely to end or stop pain New value: Completely to end or stop the pain
2013-02-06	1.1	Columbia-Suicide Severity Rating Scale Baseline (C-SSRS BASELINE) Revised: QSSCAT added to be compatible with all CSSR-S questionnaires QSTPT replaced with QNAM=EVLINTTX to be compatible with all CSSR-S questionnaires using evaluation intervals Corrected "Dose not apply", associated with the Most Severe Ideation, Reasons on page 9 to "Does not apply". Added QS terminology reference
2012-08-07	1.0	Columbia-Suicide Severity Rating Scale Baseline (C-SSRS BASELINE) Released
2012-03-03	0.1	Columbia-Suicide Severity Rating Scale Baseline (C-SSRS BASELINE) Draft

1 Introduction

This document describes the CDISC implementation of the Columbia-Suicide Severity Rating Scale Baseline (C-SSRS BASELINE) instrument.

CDISC does not modify questionnaires, ratings, and scales (QRS) instruments to meet Clinical Data Acquisition Standards Harmonization (CDASH) case report form (CRF) standards.

The representation of data collected for this instrument is based on the Study Data Tabulation Model Implementation Guide (SDTMIG) Questionnaires (QS) domain model, which can be found on the CDISC website at: https://www.cdisc.org/standards/foundational/sdtmig.

These specific implementation details for this instrument are meant to be used in conjunction with the SDTMIG. All CDISC QRS documentation packages can be found on the CDISC website at: https://www.cdisc.org/standards/foundational/qrs.

The CDISC Intellectual Property Policy can be found on the CDISC website at: https://www.cdisc.org/about/bylaws.

1.1 Representations and Warranties, Limitations of Liability, and Disclaimers

This document is a supplement to the SDTMIG for Human Clinical Trials and is covered under Appendix F of that document, which describes representations, warranties, limitations of liability, and disclaimers. Please see Appendix F of the SDTMIG for a complete version of this material.

CDISC specifies how to structure the data that has been collected in a database, not what should be collected or how to conduct clinical assessments or protocols. CDISC disclaims any liability for your use of this material.

Although the United States Food and Drug Administration (US FDA) has provided input with regard to this supplement, this input does not constitute US FDA endorsement of any particular instrument.

2 Copyright Status

The Research Foundation for Mental Hygiene, Inc. owns the copyright for the C-SSRS BASELINE instrument and has granted CDISC permission to include this supplement in the CDISC inventory of QRS data standards supplements. Hence, CDISC developed QSTESTCD and QSTEST for each item based on the actual text on the instrument.

The CDISC documentation of this instrument consists of: (1) controlled terminology, (2) standard database structure with examples, and (3) CRF(s) annotated with the CDISC SDTMIG variables with submission values.

Information for Reviewers

The CRF is attached at the top of the Wiki. When you click the paperclip image, you will find the file for the annotated CRF.

Note: CDISC Controlled Terminology is maintained by National Cancer Institute (NCI) Enterprise Vocabulary Services (EVS). The most recent version should be accessed through the CDISC website at: https://www.cdisc.org/standards/terminology/controlled-terminology.

CDISC has developed this documentation at no cost to the copyright holder or any additional cost to users of the instrument beyond the normal license fees charged by the copyright holder.

CDISC acknowledges The Research Foundation for Mental Hygiene, Inc. for the approval to include the C-SSRS BASELINE in the CDISC data standards.

Reference for the C-SSRS BASELINE:

(C-SSRS) Since Last Visit Version 1/14/2009 (Posner, K.; Brent, D.; Lucas, C.; Gould, M.; Stanley, B.; Brown, G.; Fisher, P.; Zelazny, J.; Burke, A.; Oquendo, M.; Mann, J.; copyright 2008 The Research Foundation for Mental Hygiene, Inc.)
No part of the C-SSRS SINCE LAST VISIT Version 1/14/2009 may be reproduced, distributed, or transmitted in any form or by any means, including photocopying, recording, or other electronic or mechanical methods, without the prior written permission of The Research Foundation for Mental Hygiene, Inc. and payment of any applicable fees. Copyright 2008 The Research Foundation for Mental Hygiene, Inc. All rights reserved.

3 The QS Domain Model

3.1 Assumptions for the QS Domain Model

All assumptions and business rules described in the SDTMIG QS domain are applicable to this supplement. Additional assumptions specific to the C-SSRS BASELINE are listed below.

The C-SSRS SINCE LAST VISIT is a suicidal ideation rating scale. It's a standard questionnaire administered on a CRF that is typically used in clinical trials to identify subjects at risk for suicidal ideation and behavior.

The questionnaire is divided into 3 sections namely Suicidal Ideation, Intensity of Ideation and Suicidal Behavior.
1. The first section, "SUICIDAL IDEATION", contains 5 items (QSTESTCD = "CSS0201" - "CSS0205") with QSORRES = "Yes" or "No" and QSSTRESC = "Y" or "N". If QSORRES = "Yes", then descriptions are represented in items QSTESTCD = "CSS0101A" - "CSS0105A". QSSTRESN is null for these items.
2. The second section "INTENSITY OF IDEATION" contains 6 items (QSTESTCD = "CSS0106" - "CSS0111") rating the most severe ideation with responses represented with a numeric score (either "0-5" or "1-5") and associated descriptive text. If "Most Severe Ideation" (QSTESTCD = "CSS0106") is present, "Description of Ideation" (QSTESTCD = "CSS0106A") is collected as free text. For this section of the C-SSRS BASELINE, QSORRES is populated with the text description while the numeric rating is represented in the standardized character and numeric result variables QSSTRESC and QSSTRESN.
3. The third section, "SUICIDAL BEHAVIOR" contains 6 items (QSTESTCD = "CSS0112", "CSS0114", "CSS0115", "CSS0117", "CSS0119", and "CSS0120") with QSORRES = "Yes" or "No" and QSSTRESC = "Y" or "N". If QSORRES = "Yes", then descriptions are represented in items QSTESTCD = "CSS0113A", "CSS0116A", "CSS0118A", and "CSS0119A". QSSTRESN is null for these items. A "Total # of Attempts" (QSTESTCD = "CSS0113"), "Total # of interrupted" (QSTESTCD = "CSS0116") and "Total # of aborted" (QSTESTCD = "CSS0118) is collected in QSORRES. "Answer for Actual Attempts Only" contains "Most Recent Attempt Date" (CSS0121A), "Most Lethal Attempt Date" (QSTESTCD = "CSS0122A"), and "Initial/First Attempt Date" (CSS0123A) collected in QSORRES. "Actual Lethality/Medical Damage" for "Most Recent Attempt", "Most Lethal Attempt" and "Initial/First Attempt" (QSTESTCD = "CSS0121B", "CSS0122B", and "CSS0123B") and "Potential Lethality" (QSTESTCD = "CSS0121C", "CSS0122C", and "CSS0123C") are represented with a numeric score (either "0-5" or "0-2") and descriptive text. For this section of the C-SSRS BASELINE, QSORRES is populated with the text description while the numeric rating is represented in the standardized character and numeric result variables QSSTRESC and QSSTRESN.
The time period of evaluation for the C-SSRS BASELINE is populated in the QSEVINTX field as an evaluation interval text value, since it cannot be precisely described as an ISO 8601 duration. The evaluation interval for the C-SSRS BASELINE is "Lifetime: Time He/She Felt Most Suicidal" (QSEVINTX = "LIFETIME").
Items are divided into 3 subcategories represented in QSSCAT: "SUICIDAL IDEATION", "INTENSITY OF IDEATION" and "SUICIDAL BEHAVIOR".
Some items on the C-SSRS BASELINE may be not done due to conditional branching. Items determined for conditional branching in the C-SSRS BASELINE are as follows:
1. If QSTESTCD = "CSS0101" and "CSS0102" have QSORRES = "No", then the logic branches to QSTESTCD = "CSS0112" and QSTESTCD = "CSS0103" - "CSS0111" will not be done.
2. Items QSTESTCD = "CSS0101A" - "CSS0105A" are only completed when the response to the preceding items (QSTESTCD = "CSS0101" - "CSS0105") is "Yes"; otherwise they are not done.
3. If QSTESTCD = "CSS0112" has QSORRES = "No", then the logic branches to QSTESTCD = "CSS0114" and QSTESTCD = "CSS0113", "CSS0113A", "CSS0121A", "CSS0121B", "CSS0121C", "CSS0122A", "CSS0122B", "CSS0122C", and "CSS0123A", "CSS0123B", "CSS0123C", will not be done.
4. If QSTESTCD = "CSS0115" has QSORRES = "No", then the logic branches to QSTESTCD = "CSS0117" and QSTESTCD = "CSS0116" and "CSS0116A" will not be done.
5. If QSTESTCD = "CSS0117" has QSORRES = "No", then the logic branches to QSTESTCD = "CSS0119" and QSTESTCD = "CSS0118" and "CSS0118A" will not be done.
6. If QSTESTCD = "CSS0119" has QSORRES = "No", then the logic branches to QSTESTCD = "CSS0120" and QSTESTCD = "CSS0119A" will not be done.
7. If QSTESTCD = "CSS0121B", "CSS0122B", and "CSS0123B" have QSORRES = "1", "2", "3", "4", or "5", then QSTESTCD = "CSS0121C", "CSS0122C", and "CSS0123C" will not be done.
A derived record is created and a QS supplemental qualifier variable is used to indicate an item was conditionally branched. When an item is not done due to conditional branching, it is represented as follows:
1. QSDRVFL = "Y".
2. QNAM = “QSCBRFL”, QLABEL = “Conditional Branched Item Indicator “, QVAL = “Y”. (This is a QS supplemental qualifier variable.)
3. QSSTAT = "NOT DONE", and QSREASND is missing
4. QSORRES, QSSTRESC and QSSTRESN are set to null (missing)
Records are created in qs.xpt for every item on the sponsor's version of the instrument.
1. For items not done due to conditional branching, refer to assumptions 4 and 5.
2. In the unexpected situation where the reason is unknown, then QSORRES, QSSTRESC and QSSTRESN are all missing, QSSTAT = "NOT DONE", and QSREASND is missing.
Some responses to the C-SSRS SINCE LAST VISIT items exceeded the 200-character limit for the QSORRES variable and needed to be reduced to fewer than 200 characters. Section 4, SDTM Mapping Strategy, indicates which item responses were revised in order to fit the 200-character limit.
Terminology
1. QSCAT, QSTESTCD, and QSTEST values are included in CDISC Controlled Terminology.
2. A full list of value sets for the qualifier, timing, and result fields is provided in Section 4, SDTM Mapping Strategy.

3.2 Example for the C-SSRS BASELINE QS Domain Model

The C-SSRS BASELINE example below shows the terminology used to implement the instrument in the QS domain. This example shows the data for 1 subject collected at the baseline visit and another subject at baseline and visit 2 for the C-SSRS BASELINE instrument. The example uses CDISC Controlled Terminology for QSTESTCD, QSTEST, and QSCAT. All original results, matching the CRF item response text, are represented in QSORRES. This result is then represented as a standard numeric score in QSSTRESN and as a standard character representation in QSSTRESC. When a result is character only, the result is transformed into the standard character representation in QSSTRESC and QSSTRESN is null.

The table represents the items from the C-SSRS BASELINE instrument.

Rows 13-14:	Items 11 and 12 are presented for illustrative purposes only. When the instrument is conducted, only one will be represented based on the CRF instructions. In this example, Item 12 would not appear in the actual dataset and has result values of "XXX".
Rows 15-16:	Items 13 and 14 are presented for illustrative purposes only. When the instrument is conducted, only one will be represented based on the CRF instructions. In this example, Item 14 would not appear in the actual dataset and has result values of "XXX".
Row 33:	The total score does not have an evaluation interval value represented, since there is a mixture of evaluation interval values with items 13 and 14 that differ from the remaining items on the CRF.

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qs.xpt

Row	STUDYID	DOMAIN	USUBJID	QSSEQ	QSTESTCD	QSTEST	QSCAT	QSSCAT	QSORRES	QSSTRESC	QSSTRESN	QSSTAT	QSREASND	QSLOBXFL	QSDRVFL	VISITNUM	QSDTC	QSEVINTX
1	STUDYX	QS	2324-P0001	1	CSS0101	CSS01-Wish to be Dead	C-SSRS BASELINE	SUICIDAL IDEATION	Yes	Y				Y		1	08/19/2022	BASELINE
2	STUDYX	QS	2324-P0001	2	CSS0101A	CSS01-Wish to be Dead, Describe	C-SSRS BASELINE	SUICIDAL IDEATION	Fall asleep and not wake up	Fall asleep and not wake up				Y		1	08/19/2022	BASELINE
3	STUDYX	QS	2324-P0001	3	CSS0102	CSS01-Non-Specific Suicidal Thought	C-SSRS BASELINE	SUICIDAL IDEATION	Yes	Y				Y		1	08/19/2022	BASELINE
4	STUDYX	QS	2324-P0001	4	CSS0102A	CSS01-Non-Specific Suicid Thought, Descr	C-SSRS BASELINE	SUICIDAL IDEATION	I thought about taking an overdose but I never made a specific plan as to when	I thought about taking an overdose but I never made a specific plan as to when				Y		1	08/19/2022	BASELINE
5	STUDYX	QS	2324-P0001	5	CSS0103	CSS01-Suicidal Ideation-No Intent	C-SSRS BASELINE	SUICIDAL IDEATION	No	N				Y		1	08/19/2022	BASELINE
6	STUDYX	QS	2324-P0001	6	CSS0103A	CSS01-Suicidal Ideation-No Intent, Descr	C-SSRS BASELINE	SUICIDAL IDEATION				NOT DONE		Y	Y	1	08/19/2022	BASELINE
7	STUDYX	QS	2324-P0001	7	CSS0104	CSS01-Ideation With Intent, No Plan	C-SSRS BASELINE	SUICIDAL IDEATION	Yes	Y				Y		1	08/19/2022	BASELINE
8	STUDYX	QS	2324-P0001	8	CSS0104A	CSS01-Ideation With Intent No Plan Descr	C-SSRS BASELINE	SUICIDAL IDEATION	I’ve thought about killing myself and how	I’ve thought about killing myself and how				Y		1	08/19/2022	BASELINE
9	STUDYX	QS	2324-P0001	9	CSS0105	CSS01-Ideation With Plan/Intent	C-SSRS BASELINE	SUICIDAL IDEATION	No	N				Y		1	08/19/2022	BASELINE
10	STUDYX	QS	2324-P0001	10	CSS0105A	CSS01-Ideation With Plan/Intent, Descr	C-SSRS BASELINE	SUICIDAL IDEATION				NOT DONE		Y	Y	1	08/19/2022	BASELINE
11	STUDYX	QS	2324-P0001	11	CSS0106	CSS01-Most Severe Ideation	C-SSRS BASELINE	INTENSITY OF IDEATION	1	1	1			Y		1	08/19/2022	BASELINE
12	STUDYX	QS	2324-P0001	12	CSS0106A	CSS01-Most Severe Ideation, Description	C-SSRS BASELINE	INTENSITY OF IDEATION	Wish to be Dead	Wish to be Dead				Y		1	08/19/2022	BASELINE
13	STUDYX	QS	2324-P0001	13	CSS0107	CSS01-Most Severe Ideation, Frequency	C-SSRS BASELINE	INTENSITY OF IDEATION	Once a week	2	2			Y		1	08/19/2022	BASELINE
14	STUDYX	QS	2324-P0001	14	CSS0108	CSS01-Most Severe Ideation, Duration	C-SSRS BASELINE	INTENSITY OF IDEATION	4-8 hours/most of day	4	4			Y		1	08/19/2022	BASELINE
15	STUDYX	QS	2324-P0001	15	CSS0109	CSS01-Most Severe Ideation, Control	C-SSRS BASELINE	INTENSITY OF IDEATION	Does not attempt to control thoughts	0	0			Y		1	08/19/2022	BASELINE
16	STUDYX	QS	2324-P0001	16	CSS0110	CSS01-Most Severe Ideation, Deterrents	C-SSRS BASELINE	INTENSITY OF IDEATION	Does not apply	0	0			Y		1	08/19/2022	BASELINE
17	STUDYX	QS	2324-P0001	17	CSS0111	CSS01-Most Severe Ideation, Reasons	C-SSRS BASELINE	INTENSITY OF IDEATION	Mostly to get attention, revenge or a reaction from others	2	2			Y		1	08/19/2022	BASELINE
18	STUDYX	QS	2324-P0001	18	CSS0112	CSS01-Actual Attempt	C-SSRS BASELINE	SUICIDAL BEHAVIOR	Yes	Y				Y		1	08/19/2022	BASELINE
19	STUDYX	QS	2324-P0001	19	CSS0113	CSS01-Number of Actual Attempts	C-SSRS BASELINE	SUICIDAL BEHAVIOR	5	5	5			Y		1	08/19/2022	BASELINE
20	STUDYX	QS	2324-P0001	20	CSS0113A	CSS01-Actual Attempt, Describe	C-SSRS BASELINE	SUICIDAL BEHAVIOR	To feel better	To feel better				Y		1	08/19/2022	BASELINE
21	STUDYX	QS	2324-P0001	21	CSS0114	CSS01-Non-suicidal Self-injurious Behav	C-SSRS BASELINE	SUICIDAL BEHAVIOR	No	N				Y		1	08/19/2022	BASELINE
22	STUDYX	QS	2324-P0001	22	CSS0115	CSS01-Interrupted Attempt	C-SSRS BASELINE	SUICIDAL BEHAVIOR	Yes	Y				Y		1	08/19/2022	BASELINE
23	STUDYX	QS	2324-P0001	23	CSS0116	CSS01-Number of Interrupted Attempts	C-SSRS BASELINE	SUICIDAL BEHAVIOR	1	1	1			Y		1	08/19/2022	BASELINE
24	STUDYX	QS	2324-P0001	24	CSS0116A	CSS01-Interrupted Attempt, Describe	C-SSRS BASELINE	SUICIDAL BEHAVIOR	Stopped from overdose	Stopped from overdose				Y		1	08/19/2022	BASELINE
25	STUDYX	QS	2324-P0001	25	CSS0117	CSS01-Aborted Attempt	C-SSRS BASELINE	SUICIDAL BEHAVIOR	Yes	Y				Y		1	08/19/2022	BASELINE
26	STUDYX	QS	2324-P0001	26	CSS0118	CSS01-Number of Aborted Attempts	C-SSRS BASELINE	SUICIDAL BEHAVIOR	3	3	3			Y		1	08/19/2022	BASELINE
27	STUDYX	QS	2324-P0001	27	CSS0118A	CSS01-Aborted Attempt, Describe	C-SSRS BASELINE	SUICIDAL BEHAVIOR	Parent found my letters	Parent found my letters				Y		1	08/19/2022	BASELINE
28	STUDYX	QS	2324-P0001	28	CSS0119	CSS01-Preparatory Acts/Behavior	C-SSRS BASELINE	SUICIDAL BEHAVIOR	No	N				Y		1	08/19/2022	BASELINE
29	STUDYX	QS	2324-P0001	29	CSS0119A	CSS01-Preparatory Acts/Behavior, Descr	C-SSRS BASELINE	SUICIDAL BEHAVIOR				NOT DONE		Y	Y	1	08/19/2022	BASELINE
30	STUDYX	QS	2324-P0001	30	CSS0120	CSS01-Suicidal Behavior	C-SSRS BASELINE	SUICIDAL BEHAVIOR	Yes	Y				Y		1	08/19/2022	BASELINE
31	STUDYX	QS	2324-P0001	31	CSS0121A	CSS01-Most Recent Attempt Date	C-SSRS BASELINE	SUICIDAL BEHAVIOR	2/14/2016					Y		1	08/19/2022	BASELINE
32	STUDYX	QS	2324-P0001	32	CSS0121B	CSS01-Most Recent Attempt Damage	C-SSRS BASELINE	SUICIDAL BEHAVIOR	Moderately severe physical damage; medical hospitalization and likely intensive care required	3	3			Y			08/19/2022	BASELINE
33	STUDYX	QS	2324-P0001	33	CSS0121C	CSS01-Most Recent Attempt Potential	C-SSRS BASELINE	SUICIDAL BEHAVIOR	Behavior likely to result in death despite available medical care	2	2			Y			08/19/2022	BASELINE
34	STUDYX	QS	2324-P0001	34	CSS0122A	CSS01-Most Lethal Attempt Date	C-SSRS BASELINE	SUICIDAL BEHAVIOR	12/31/2013					Y		1	08/19/2022	BASELINE
35	STUDYX	QS	2324-P0001	35	CSS0122B	CSS01-Most Lethal Attempt Damage	C-SSRS BASELINE	SUICIDAL BEHAVIOR	Severe physical damage; medical hospitalization with intensive care required	4	4			Y			08/19/2022	BASELINE
36	STUDYX	QS	2324-P0001	36	CSS0122C	CSS01-Most Lethal Attempt Potential	C-SSRS BASELINE	SUICIDAL BEHAVIOR	Behavior likely to result in death despite available medical care	2	2			Y			08/19/2022	BASELINE
37	STUDYX	QS	2324-P0001	37	CSS0123A	CSS01-First Attempt Date	C-SSRS BASELINE	SUICIDAL BEHAVIOR	3/27/2009					Y		1	08/19/2022	BASELINE
38	STUDYX	QS	2324-P0001	38	CSS0123B	CSS01-First Attempt Damage	C-SSRS BASELINE	SUICIDAL BEHAVIOR	No physical damage or very minor physical damage	0	0			Y			08/19/2022	BASELINE
39	STUDYX	QS	2324-P0001	39	CSS0123C	CSS01-First Attempt Potential	C-SSRS BASELINE	SUICIDAL BEHAVIOR	Behavior not likely to result in injury	0	0			Y			08/19/2022	BASELINE
40	STUDYX	QS	2324-P0002	1	CSS0101	CSS01-Wish to be Dead	C-SSRS BASELINE	SUICIDAL IDEATION	No	N				Y		1	07/13/2022	BASELINE
41	STUDYX	QS	2324-P0002	2	CSS0201A	CSS01-Wish to be Dead, Describe	C-SSRS BASELINE	SUICIDAL IDEATION				NOT DONE		Y	Y	1	07/13/2022	BASELINE
42	STUDYX	QS	2324-P0002	3	CSS0102	CSS01-Non-Specific Suicidal Thought	C-SSRS BASELINE	SUICIDAL IDEATION	No	N				Y		1	07/13/2022	BASELINE
43	STUDYX	QS	2324-P0002	4	CSS0102A	CSS01-Non-Specific Suicid Thought, Descr	C-SSRS BASELINE	SUICIDAL IDEATION				NOT DONE		Y	Y	1	07/13/2022	BASELINE
44	STUDYX	QS	2324-P0002	5	CSS0103	CSS01-Suicidal Ideation-No Intent	C-SSRS BASELINE	SUICIDAL IDEATION				NOT DONE		Y	Y	1	07/13/2022	BASELINE
	…	…	…	…	…	…	…	…	…	…	…	…	…	…		…	…	…
56	STUDYX	QS	2324-P0002	17	CSS0111	CSS01-Most Severe Ideation, Reasons	C-SSRS BASELINE	INTENSITY OF IDEATION				NOT DONE		Y	Y	1	07/13/2022	BASELINE
57	STUDYX	QS	2324-P0002	18	CSS0112	CSS01-Actual Attempt	C-SSRS BASELINE	SUICIDAL BEHAVIOR	No	N				Y		1	07/13/2022	BASELINE
58	STUDYX	QS	2324-P0002	19	CSS0113	CSS01-Number of Actual Attempts	C-SSRS BASELINE	SUICIDAL BEHAVIOR				NOT DONE		Y	Y	1	07/13/2022	BASELINE
59	STUDYX	QS	2324-P0002	20	CSS0113A	CSS01-Actual Attempt, Describe	C-SSRS BASELINE	SUICIDAL BEHAVIOR				NOT DONE		Y	Y	1	07/13/2022	BASELINE
60	STUDYX	QS	2324-P0002	21	CSS0114	CSS01-Non-suicidal Self-injurious Behav	C-SSRS BASELINE	SUICIDAL BEHAVIOR	No	N				Y		1	07/13/2022	BASELINE
61	STUDYX	QS	2324-P0002	22	CSS0115	CSS01-Interrupted Attempt	C-SSRS BASELINE	SUICIDAL BEHAVIOR	No	N				Y		1	07/13/2022	BASELINE
62	STUDYX	QS	2324-P0002	23	CSS0116	CSS01-Number of Interrupted Attempts	C-SSRS BASELINE	SUICIDAL BEHAVIOR				NOT DONE		Y	Y	1	07/13/2022	BASELINE
63	STUDYX	QS	2324-P0002	24	CSS0116A	CSS01-Interrupted Attempt, Describe	C-SSRS BASELINE	SUICIDAL BEHAVIOR				NOT DONE		Y	Y	1	07/13/2022	BASELINE
64	STUDYX	QS	2324-P0002	25	CSS0117	CSS01-Aborted Attempt	C-SSRS BASELINE	SUICIDAL BEHAVIOR	No	N				Y		1	07/13/2022	BASELINE
65	STUDYX	QS	2324-P0002	26	CSS0118	CSS01-Number of Aborted Attempts	C-SSRS BASELINE	SUICIDAL BEHAVIOR				NOT DONE		Y	Y	1	07/13/2022	BASELINE
66	STUDYX	QS	2324-P0002	27	CSS0118A	CSS01-Aborted Attempt, Describe	C-SSRS BASELINE	SUICIDAL BEHAVIOR				NOT DONE		Y	Y	1	07/13/2022	BASELINE
67	STUDYX	QS	2324-P0002	28	CSS0119	CSS01-Preparatory Acts/Behavior	C-SSRS BASELINE	SUICIDAL BEHAVIOR	Yes	Y				Y		1	07/13/2022	BASELINE
68	STUDYX	QS	2324-P0002	29	CSS0119A	CSS01-Preparatory Acts/Behavior, Descr	C-SSRS BASELINE	SUICIDAL BEHAVIOR	Bought pills, Bought a gun, suicide note	Bought pills, Bought a gun, suicide note				Y		1	07/13/2022	BASELINE
69	STUDYX	QS	2324-P0002	30	CSS0120	CSS01-Suicidal Behavior	C-SSRS BASELINE	SUICIDAL BEHAVIOR	Yes	Y				Y		1	07/13/2022	BASELINE
70	STUDYX	QS	2324-P0002	31	CSS0121A	CSS01-Most Recent Attempt Date	C-SSRS BASELINE	SUICIDAL BEHAVIOR				NOT DONE		Y	Y	1	07/13/2022	BASELINE
71	STUDYX	QS	2324-P0002	32	CSS0121B	CSS01-Most Recent Attempt Damage	C-SSRS BASELINE	SUICIDAL BEHAVIOR				NOT DONE		Y	Y	1	07/13/2022	BASELINE
72	STUDYX	QS	2324-P0002	33	CSS0121C	CSS01-Most Recent Attempt Potential	C-SSRS BASELINE	SUICIDAL IDEATION				NOT DONE		Y	Y	1	07/13/2022	BASELINE
	…	…	…	…	…	…	…	…	…	…	…	…	…	…		…	…	…
78	STUDYX	QS	2324-P0002	39	CSS0123C	CSS01-First Attempt Potential	C-SSRS BASELINE	SUICIDAL BEHAVIOR				NOT DONE		Y	Y	1	07/13/2022	BASELINE
79	STUDYX	QS	2324-P0002	40	CSS0101	CSS01-Wish to be Dead	C-SSRS BASELINE	SUICIDAL IDEATION								2
80	STUDYX	QS	2324-P0002	41	CSS0201A	CSS01-Wish to be Dead, Describe	C-SSRS BASELINE	SUICIDAL IDEATION				NOT DONE				2
81	STUDYX	QS	2324-P0002	42	CSS0102	CSS01-Non-Specific Suicidal Thought	C-SSRS BASELINE	SUICIDAL IDEATION								2
82	STUDYX	QS	2324-P0002	43	CSS0102A	CSS01-Non-Specific Suicid Thought, Descr	C-SSRS BASELINE	SUICIDAL IDEATION				NOT DONE				2
83	STUDYX	QS	2324-P0002	44	CSS0103	CSS01-Suicidal Ideation-No Intent	C-SSRS BASELINE	SUICIDAL IDEATION				NOT DONE				2
	…	…	…	…	…	…	…	…	…	…	…	…	…	…		…		…
117	STUDYX	QS	2324-P0002	78	CSS0123C	CSS01-First Attempt Potential	C-SSRS BASELINE	SUICIDAL BEHAVIOR				NOT DONE				2

$warningHtml

Dataset Wrapper Debug Message

Please add a row column to your dataset.

The suppqs dataset shows the items in the qs dataset which have assigned responses (QSDRVFL = "Y") due to conditional branching.

The following is for illustrative purposes and would not really be included for the IDS-SR instrument in this template. It provides an example of what would need to be included if the instrument required supplemental qualifiers (see Section 5 Supplemental Qualifier Name Codes):

Text that would remain unchanged has been left in black:

The evaluation interval text value for data collection needs to be populated in SUPPQS as follows. The standard terminology for QNAM and QLABEL are listed below.

STUDYID	RDOMAIN	USUBJID	IDVAR	IDVARVAL	QNAM	QLABEL	QVAL	QORIG
STUDYX	QS	P0001	QSSEQ	Sequence number corresponding to row of qs.xpt that supplemental qualifier is needed for (e.g., 8)	Appropriate variable name to provide more information about data in qs.xpt, no more than 8 characters long (e.g., CONTACT).	Label for QNAM (e.g., Contact Type)	Value of QNAM variable ( e.g., SUBJECT VISIT)	CRF

4 SDTM Mapping Strategy

This section is used for reference regarding the CRF data capture and to understand the alignment of the instrument to the SDTM QS domain. It also provides guidance on how the result variables (QSORRES, QSSTRESC, and QSSTRESN) should be populated.

QSSCAT alignment with QSTESTCD

As stated in Section 3.1 assumptions, items on the C-SSRS BASELINE are grouped into subcategories. The table below includes the subcategory names along with the applicable item numbers for each category. The values of the subcategories are used to populate QSSCAT and are annotated on the CRF.

QSSCAT	QSTESTCD
SUICIDAL IDEATION	QSSS0101 - CSS0105A
INTENSITY OF IDEATION	CSS0106 - CSS0111
SUICIDAL BEHAVIOR	CSS0112 - CSS0123C

--TESTCD = "CSS0106" --TEST = "CSS01-Most Severe Ideation"

--ORRES	--STRESC	--STRESN
1	1	1
2	2	2
3	3	3
4	4	4
5	5	5

--TESTCD = "CSS0101" --TEST = "CSS01-Wish to be Dead"

--TESTCD = "CSS0102" --TEST = "CSS01-Non-Specific Suicidal Thought"

--TESTCD = "CSS0103" --TEST = "CSS01-Suicidal Ideation-No Intent"

--TESTCD = "CSS0104" --TEST = "CSS01-Ideation With Intent, No Plan"

--TESTCD = "CSS0105" --TEST = "CSS01-Ideation With Plan/Intent"

--TESTCD = "CSS0112" --TEST = "CSS01-Actual Attempt"

--TESTCD = "CSS0114" --TEST = "CSS01-Non-suicidal Self-injurious Behav"

--TESTCD = "CSS0115" --TEST = "CSS01-Interrupted Attempt"

--TESTCD = "CSS0117" --TEST = "CSS01-Aborted Attempt"

--TESTCD = "CSS0119" --TEST = "CSS01-Preparatory Acts/Behavior"

--TESTCD = "CSS0120" --TEST = "CSS01-Suicidal Behavior"

--ORRES	--STRESC
Yes	Y
No	N

--TESTCD = "CSS0107" --TEST = "CSS01-Most Severe Ideation, Frequency"

--ORRES	--STRESC	--STRESN
Less than once a week	1	1
Once a week	2	2
2-5 times in week	3	3
Daily or almost daily	4	4
Many times each day	5	5

--TESTCD = "CSS0108" --TEST = "CSS01-Most Severe Ideation, Duration"

--ORRES	--STRESC	--STRESN
Fleeting – few seconds or minutes	1	1
Less than 1 hour/some of the time	2	2
1-4 hours/a lot of time	3	3
4-8 hours/most of day	4	4
More than 8 hours/persistent or continuous	5	5

--TESTCD = "CSS0109" --TEST = "CSS01-Most Severe Ideation, Control"

--ORRES	--STRESC	--STRESN
Easily able to control thoughts	1	1
Can control thoughts with little difficulty	2	2
Can control thoughts with some difficulty	3	3
Can control thoughts with a lot of difficulty	4	4
Unable to control thoughts	5	5
Does not attempt to control thoughts	0	0

--TESTCD = "CSS0110" --TEST = "CSS01-Most Severe Ideation, Deterrents"

--ORRES	--STRESC	--STRESN
Deterrents definitely stopped you from attempting suicide	1	1
Deterrents probably stopped you	2	2
Uncertain that deterrents stopped you	3	3
Deterrents most likely did not stop you	4	4
Deterrents definitely did not stop you	5	5
Does not apply	0	0

--TESTCD = "CSS0111" --TEST = "CSS01-Most Severe Ideation, Reasons"

--ORRES	--STRESC	--STRESN
Completely to get attention, revenge or a reaction from others	1	1
Mostly to get attention, revenge or a reaction from others	2	2
Equally to get attention, revenge or a reaction from others and to end/stop the pain	3	3
Mostly to end or stop the pain (you couldn’t go on living with the pain or how you were feeling)	4	4
Completely to end or stop the pain (you couldn’t go on living with the pain or how you were feeling)	5	5
Does not apply	0	0

--TESTCD = "CSS0121B" --TEST = "CSS01-Most Recent Attempt Damage"

--TESTCD = "CSS0122B" --TEST = "CSS01-Most Lethal Attempt Damage"

--TESTCD = "CSS0123B" --TEST = "CSS01-First Attempt Damage"

--ORRES	--STRESC	--STRESN
No physical damage or very minor physical damage	0	0
Minor physical damage	1	1
Moderate physical damage; medical attention needed	2	2
Moderately severe physical damage; medical hospitalization and likely intensive care required	3	3
Severe physical damage; medical hospitalization with intensive care required	4	4
Death	5	5

--TESTCD = "CSS0121C" --TEST = "CSS01-Most Recent Attempt Potential"

--TESTCD = "CSS0122C" --TEST = "CSS01-Most Lethal Attempt Potential"

--TESTCD = "CSS0123C" --TEST = "CSS01-First Attempt Potential"

--ORRES	--STRESC	--STRESN
Behavior not likely to result in injury	0	0
Behavior likely to result in injury but not likely to cause death	1	1
Behavior likely to result in death despite available medical care	2	2

5 Supplemental Qualifier Name Codes

The instrument used as an example in this template did not require supplemental qualifiers, but this section has been included to provide guidance on those instruments which do require supplemental qualifiers. (Many instruments do not require it.) Text that always will be in the section when it is included has been left black.

Additional rows will be required in the suppqs.xpt dataset for each supplemental qualifier needed.

Remove Section 5 if it does not apply to the new instrument.

The following table contains additional standard name codes for use in the Supplement Qualifiers for Questionnaires (SUPPQS) special purpose dataset.

QNAM	QLABEL	QVAL
QSCBRFL	Conditional Branching Item Indicator	Y

End of Document

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Columbia-Suicide Severity Rating Scale Baseline (C-SSRS BASELINE)